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Comparison of insulin degludec (IDeg)/insulin Aspart (IAsp) co-formulation therapy twice-daily with free combination of GLP-1 receptor agonist liraglutide plus insulin deguldec in Tochigi: IDEAL Trial
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  • Yoshimasa Aso,
  • Teruo Jojima,
  • Isao Usui,
  • Yoshihisa Takada,
  • Ken Tomotsune,
  • Yasuko Chiba,
  • Mihoko Matsumura,
  • Nobuya Fujita,
  • Hisamoto Kuroda,
  • Shunichi Murano,
  • Minoru Sato
Yoshimasa Aso
Dokkyo Medical University
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Teruo Jojima
Dokkyo Ika Daigaku
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Isao Usui
Dokkyo Ika Daigaku
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Yoshihisa Takada
Takada Clinic
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Ken Tomotsune
Saiseikai Utsunomiya Byoin
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Yasuko Chiba
Nagasaki Hospital
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Mihoko Matsumura
Kamitsuga General Hospital
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Nobuya Fujita
Fujita Clinic
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Hisamoto Kuroda
Green Clinic
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Shunichi Murano
TMC Tochigi Medical Center
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Minoru Sato
NHO Utsunomiya National Hospital
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Abstract

Aim: We compared the efficacy and safety of insulin degludec/insulin aspart co-formulation (IDegAsp) twice-daily to a free combination of basal insulin degludec and GLP-1 receptor agonist liraglutide (IDeg+Lira) once-daily for patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs. Subjects and Methods: Eligible patients were randomly allocated at a 1:1 ratio to receive either the once-daily dual-injection of IDeg+Lira (n=24) or twice-daily single-injection of IDegAsp (n=28). The primary endpoints were: HbA1c changes over 52 weeks of treatment and the percentage of participants achieving HbA1c<7.0% at week 52. Results: After 52 weeks, HbA1c decreased by 0.3% in the IDegAsp group and by 0.7% in the IDeg+Lira group. The HbA1c reduction was greater in the IDeg+Lira group than in the IDegAsp group. 19% of patients on IDegAsp versus 40% on IDeg+Lira achieved HbA1c<7.0%. Pre-breakfast and pre-dinner blood glucose at 52 weeks were significantly lower in the IDeg+Lira group than in the IDegAsp group. The reduction in body mass index (BMI) was greater in the IDeg+Lira group than in the IDegAsp group throughout the study period. The confirmed hypoglycemia rates were 1.32 and 0.69 per patient/year of exposure to IDegAsp and IDeg+Lira, respectively. Conclusions: In patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs, treatment with the once-daily dual-injection of IDeg+Lira compared to the twice-daily single-injection of IDegAsp showed no significant difference in glycemic control, but with a slightly larger reduction in HbA1c at 52 weeks, and statistically superior weight loss.

Peer review status:Published

02 Jun 2020Submitted to International Journal of Clinical Practice
04 Jun 2020Submission Checks Completed
04 Jun 2020Assigned to Editor
04 Jun 2020Reviewer(s) Assigned
18 Jun 2020Review(s) Completed, Editorial Evaluation Pending
16 Jul 20201st Revision Received
16 Jul 2020Submission Checks Completed
16 Jul 2020Assigned to Editor
16 Jul 2020Reviewer(s) Assigned
22 Aug 2020Review(s) Completed, Editorial Evaluation Pending
18 Sep 2020Editorial Decision: Accept
Apr 2021Published in International Journal of Clinical Practice volume 75 issue 4. 10.1111/ijcp.13734